Apotex Biosimilar Goes To FDA, But May Enter Crowded Market
This article was originally published in PharmAsia News
Pegfilgrastim product, a collaboration with the Indian firm Intas, may have to compete with multiple filgrastim products, along with its reference biologic, Amgen’s Neulasta.
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Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.
Amgen is planning to launch four new drugs in 2015 while cutting costs by $1.5 billion by 2018, all part of a big push outlined by CEO Robert Bradway Oct. 28 to drive long-term growth as Amgen’s legacy brands come under pressure.